The present invention relates to a urine flow control device, such as an incontinence device.
Incontinence is the inability of any of the physical organs to restrain discharges of their contents; in the present context, incontinence is considered the involuntary discharge or evacuation of urine. This could e.g. be during movement, such as jumping, or when sneezing or laughing where persons suffering from incontinence experience problems.
Persons suffering from incontinence are often compelled to wear a pad for collecting urine being discharged from the urethra. In addition, persons suffering from incontinence may experience that the discharge of urine causes unwanted odours, which may cause the person to feel uncomfortable and embarrassed. Therefore, there is a need for a device hindering uncontrolled discharge of urine.
Some persons, on the other hand, have problems emptying their bladder. This may be due to low detrusor activity, which is associated to neurological or myogenic conditions. It may also be due to patient age factors, medication or bladder outlet obstruction. Such patients insert catheters when emptying the bladder. Either they catheterize themselves, have nurses perform the catheterization, or they carry a catheter permanently.
Such patients may be helped by wearing a valve catheter, as this can eliminate the need for catheterization every time the bladder needs emptying.
U.S. Pat. No. 5,476,434 discloses an incontinence device with an insertion/mounting tool and having in one embodiment a duck bill valve, which by its nature opens and reopens readily through sideways bending of the flat rubber lips defining the valve opening. In another embodiment a ball valve is used; the ball valve is part of a plug inserted into the device after it has been placed in the urethra by the insertion/mounting tool, and the ball is configured to be attracted by a magnetic disc. The ball is displaced along the length of the device by a spring upon removal of the magnet.
It is an object of the present invention to provide an alternative to the prior art whereby reinsertion, using the insertion/mounting tool, of the catheter once removed is made difficult. Such reuse may cause urinary tract infections. The mounting tool may preferably be in the form of a pin, such as a generally cylindrical cross-section pin, movable within the device along a path, which normally is along a central axis of the device.
Another object is to provide a catheter offering an improved usability and comfort.
The above described object and several other objects are intended to be obtained in a first aspect of the invention by providing a urine flow control device, such as an incontinence device, for insertion into a urethra, device comprising: a body having a first end and an opposite second end and a middle part connecting the first end and the second end, a hollow chamber formed in the middle part allowing a mounting tool to extend from the first end to the second end, a fluid channel defined from the second end to the first end via the hollow chamber, a head part at the first end, the head part being integral with said body and comprising a chamber with a displaceable valve member and a valve seal surface, the head part formed so that when a mounting tool is positioned in the device the valve member is displaced inside the head part by the mounting tool and when the mounting tool is not in the device the valve member seals the valve seal surface so as to seal the fluid channel, the head part having an opening for receiving the mounting tool and for urine discharge, the second end being formed so that the distal end of the mounting tool elongates the body when inserted in the hollow chamber and applying an elongating force to the body.
Further embodiments are defined in the dependent claims.
In one embodiment there is provided a urine flow control device, such as an incontinence device, for insertion into a urethra, the device comprising: a body having a first end and an opposite second end and a middle part connecting the first end and the second end, a hollow chamber formed in the middle part allowing a mounting tool to extend from the first end to the second end, the first end having an opening for receiving the mounting tool, the second end being formed so that the body elongates when the mounting tool is inserted in the hollow chamber and applies a force to the second end, a head part at the opening of the first end, the head part comprising a chamber, a valve sealing surface and a valve member, the head part formed so that when the mounting tool is inserted into the device the valve member is displaced from the valve sealing surface and when the mounting tool is not inserted into the device the valve member is in a resting position where the head part abuts the valve member so that the valve member hinders flow.
In yet another embodiment there is provided a urine flow control device, such as an incontinence device, for insertion into a urethra, the device comprising: a body having a first end and an opposite second end and a middle part connecting the first end and the second end, a hollow chamber formed in the middle part allowing a mounting tool to extend from the first end to the second end, a fluid channel defined from the second end to the first end via the hollow chamber, a head part at the first end, the head part comprising a chamber and a valve member and a valve seal surface, a tab formed on the outside of the head so that when the tab is pulled by a user the valve member is displaced inside the head part and when the tab is released the valve member seals the valve seal surface so as to seal the fluid channel.
It is an advantage to provide a device the operation of which is as easy as possible for the user. Devices or plugs that have to be completely removed from the urethra in order to open for urine flow are inconvenient. It is better to have a device that can stay for several days in the urethra once mounted. In this case, a valve is needed in the device. Such a valve must be easy to open and close. It is especially advantageous if the valve closes automatically once the user decides not to provide the means that opens the valve.
It is further an advantage to provide a location of the valve that prevents the entrance of contaminations e.g. hair to the sealing surfaces.
It is further an advantage to provide a device that is difficult to reinsert in the urethra, once it is removed therefrom. This prevents reuse and the potential introduction of bacteria into the urethra. In the present invention, this is ensured by delivering a package with the device having a mounting tool inserted. This mounting tool is mandatory for the insertion of the device. Once the device is inserted, the mounting tool is withdrawn and removed from the device. The withdrawal of the mounting tool allows the valve member to move into the position where it seals against the valve sealing surface. In addition to this, the valve member blocks for any re-insertion of the mounting tool. This prevents or at least hinders the re-use of the device.
It is further an advantage to provide a device where the valve can be opened without touching the device. This is especially beneficial in cases where the user needs the assistance from a nurse or other persons in order to open the valve. This provides a better comfort and is less intimidating for the user as well as more hygienic in general.
Advantageously the valve member may have permanent magnetic properties. This will e.g. allow a user move the valve member away from the sealing surface and open the valve by placing a magnetic material or a magnet close to the device. Thus, the urine flow control device may be used with an external device providing magnetic attraction to the valve member so that the valve member is displaced from the resting position thereby allowing fluid to flow through the opening.
By magnet is meant a material that generates a magnetic field, and by magnetic is meant a material that is attracted by a magnet.
The device may easily be inserted in a urethra by the user herself and she can herself exchange or replace the device when needed. The mounting tool eases the mounting procedure as the mounting tool extends the length of the device whereby the outer diameter of the device is reduced. This promotes mounting, and further allows the diameter of the device to be designed for maximum retention force when mounted in the urethra.
In an embodiment, the valve member is not a magnet in itself, but may be magnetic and thereby moved by an external magnet so as to allow urine to pass through the device, meaning that the valve member may be made fully or partially from a magnetic material.
Advantageously the body of the device may have a tapering outer geometry so as to provide a surface abutting the inner wall of the urethra for a substantial part of the body of the device. This makes the device more prone to move towards the bladder, when mounted in a urethra, than to fall out, e.g. while the user is walking. The head of the device ensures that the device does not move longer into the bladder than intended.
Advantageously a magnetic part may be located between the valve member and the second end of the body. This provides an increased mechanical stability to the area there the valve member abuts the opening and may also provide a force between the valve member and the metal part if the valve member is a magnet.
The second end may comprise a protrusion for engaging a wall of a bladder or the innermost part of the urethra where this widens into the bladder. This increases the force needed to retract the device from the urethra, and thereby reduces the risk for unintended loss of the device.
When the mounting tool is inserted into the flow control device it is an advantage that it extends the length of the body when pushed towards the second end. This extension reduces the maximum diameter, or at least the diameter at certain places or regions of the device.
The valve member may be spherical, but other geometries may be used. One advantage of using a spherical or ball-shaped geometry is that the valve member can seal a circular opening independent of the orientation of the valve member. A further advantage is that a polished ball shape can easily be moved by the silicones elasticity or a magnetic force, as this shape has no edges that can hinder the movement to and from the sealing surface.
Advantageously a rigid, preferably metal, member may be embedded in the body at the first end so that the opening maintains a specific geometry when abutted by the valve member. The specific geometry may be circular, which is especially advantageous when the valve member is spherical as discussed above. In addition, a non-metal rigid member may be useful, as this too can ensure a circular sealing surface.
Both for production reasons, but also for the mechanical strength of the device and security and comfort of the user, the body of the device may be formed in one single piece, e.g. by silicone injection moulding. This also reduces the risk of parts falling off or dismantling while the device is in use.
For increased comfort for the user, the flexible parts of the device may be formed from silicone or polyurethane, or other biocompatible materials.
The device may comprise the head part having a tap positioned so that when the device is located in a urethra and the tab is pulled, the head part is moved so that the force that presses the valve member against the valve sealing surface is reduced, whereby the urine pressure can open the valve and urine can flow. Furthermore, the head will pivot so that the resulting urine flow will leave the orifice in a direction so that it does not come in contact with the fingers of the user. This further allows a user to discharge urine without being in possession of any tools. The tab may also be used in conjunction with an external device that applies a force to the valve member and further opens the valve for an increased flow of urine.
By pulling even harder in the tabs, the device is elongated or extended and the wide part of the device is forced to reduce its diameter, so that the device can pulled out of the urethra without the need for any tools. Medical grade silicone has sufficient strength for a safe operation.
The head part of the flow control device ensures that the first end of the body stays at the external wall of the urethra so that the entire device cannot enter the urethra. The shape and varying width along the length of the device ensures that it fits into the urethra so that no urine can pass between the device and the inner wall of the urethra. The tapered outer shape and the wide bulb ensure that the device stays in place once it is mounted.
Advantageously a coating may be applied to the outer surface of the device. The coating may be a bacteria reducing agent so as to reduce the risk of urinary tract infection. The coating may further have friction reducing properties for an eased mounting and withdrawal of the device from the urethra.
Advantageously the valve member may comprise a coating layer for reducing corrosion of the valve member and/or for reducing deposits and/or for improving cleaning and/or for improving biocompatibility.
A second aspect of the present invention relates to a package comprising a device according to the first aspect and a magnetic device or tool for opening the valve. This allows a user to easily obtain a complete package from e.g. a pharmacy or the like without having the trouble of locating a suitable tool, i.e. something with sufficient magnetic attraction to open the valve.
A package may be provided wherein a mounting tool is inserted into the device. As described elsewhere the operation of entering a mounting tool into a device according to the present invention is difficult and should not be performed by the user herself. By provided a mounting tool inserted into the urine flow control device in a package the user will be able to easily insert the device into the urethra.
The package may further comprise a lubricant for application to the device. This is an advantage to the user when applying the device to the urethra and ensures that a suitable medical grade lubricant is used.
The surface of the device may further be pre-lubricated so that it is ready for use and insertion upon opening the package and the user thereby does not have to apply the lubricant herself or risk that the lubricant and device are in some way incompatible.
This lubricant may further contain a mild sedative that makes the mounting of and adaptation to the device more comfortable for the user.
The package may further comprise an anti-bacterial agent in a container. This may be applied so as to reduce the risk of urinary tract infection.
The first and second aspect of the present invention may each be combined with any of the other aspects. These and other aspects of the invention will be apparent from and elucidated with reference to the embodiments described hereinafter.